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==Indications==
==Indications==
HPV is a virus, usually transmitted sexually, which can cause cervical cancer in a small percentage of those women genital infected. Cervarix is a preventative HPV vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV types other than HPV types 16 and 18, so experts continue to recommend routine cervical [[pap test|Pap smear]]s even for women who have been vaccinated. Without continued screening the number of cervical cancers preventable by vaccination alone is less than the number of cervical cancers prevented by regular screening alone.<ref name="harperreview">{{cite doi|10.1097/GCO.0b013e328332c910}}</ref><ref>{{cite web|url=http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html|title=An Interview with Dr. Diane M. Harper, HPV Expert|first=Marcia G. Yerman |date=28 December 2010|accessdate=12 January 2010}}</ref>
HPV is a virus, usually transmitted sexually, which can cause cervical cancer in a small percentage of those women genital infected. Cervarix is a preventative HPV vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV types other than HPV types 16 and 18, so experts continue to recommend routine cervical [[pap test|Pap smear]]s even for women who have been vaccinated. Without continued screening the number of cervical cancers preventable by vaccination alone is less than the number of cervical cancers prevented by regular screening alone.<ref name="harperreview">{{cite doi|10.1097/GCO.0b013e328332c910}}</ref><ref>{{cite web|url=http://www.huffingtonpost.com/marcia-g-yerman/an-interview-with-dr-dian_b_405472.html|title=An Interview with Dr. Diane M. Harper, HPV Expert|first=Marcia G. Yerman |date=28 December 2010|accessdate=12 January 2010}}</ref>


⚫
Cervarix is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. Cervarix is approved for use in females 10 through 25 years of age. <ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Highlights of Prescribing Information| accessdate=2010-08-03}}</ref>


⚫
'''Limitations of Use and Effectiveness '''<ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Highlights of Prescribing Information| accessdate=2010-08-03}}</ref>
⚫
* Cervarix does not provide protection against disease due to all HPV types.
⚫
* Cervarix has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
⚫
* Females should continue to adhere to recommended cervical cancer screening procedures.
⚫
* Vaccination with Cervarix may not result in protection in all vaccine recipients.


==Administration==
⚫
Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm. Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes. <ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Highlights of Prescribing Information| accessdate=2010-08-03}}</ref>


==Ingredients==
==Ingredients==
Line 90: Line 104:


==Contraindications==
==Contraindications==
⚫
* Severe allergic reactions to any component of Cervarix. <ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Cervarix Prescribing Information| accessdate=2010-08-02}}</ref>

⚫
Cervarix is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. Cervarix is approved for use in females 10 through 25 years of age. <ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Highlights of Prescribing Information| accessdate=2010-08-03}}</ref>


⚫
'''Limitations of Use and Effectiveness '''<ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Highlights of Prescribing Information| accessdate=2010-08-03}}</ref>
⚫
* Cervarix does not provide protection against disease due to all HPV types.
⚫
* Cervarix has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
⚫
* Females should continue to adhere to recommended cervical cancer screening procedures.
⚫
* Vaccination with Cervarix may not result in protection in all vaccine recipients.


⚫
'''Administration'''<ref>{{cite web| url=http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf| title=Highlights of Prescribing Information| accessdate=2010-08-03}}</ref>

⚫
Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm. Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes.


==Use==
==Use==

Revision as of 15:55, 9 August 2010

See also: HPV vaccine
Cervarix
Vaccine description
Targethuman papillomavirus (Types 16 and 18)
Vaccine typeProtein subunit
Clinical data
Routes of
administration		injection
ATC code
Legal status
Legal status

Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV).

Cervarix is designed to prevent infection from HPV types 16 and 18, which currently cause about 70% of cervical cancer cases. Type 16 is also associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.[1] Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials.[2] Cervarix is also formulated with AS04, a proprietary adjuvant that has been found to boost the immune system response for a longer period of time.[3]

Cervarix is manufactured by GlaxoSmithKline. An alternative product, from Merck & Co., is known as Gardasil.

Indications

HPV is a virus, usually transmitted sexually, which can cause cervical cancer in a small percentage of those women genital infected. Cervarix is a preventative HPV vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV types other than HPV types 16 and 18, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated. Without continued screening the number of cervical cancers preventable by vaccination alone is less than the number of cervical cancers prevented by regular screening alone.[4][5]


Cervarix is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. Cervarix is approved for use in females 10 through 25 years of age. [6]


Limitations of Use and Effectiveness [7]

  • Cervarix does not provide protection against disease due to all HPV types.
  • Cervarix has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
  • Females should continue to adhere to recommended cervical cancer screening procedures.
  • Vaccination with Cervarix may not result in protection in all vaccine recipients.


Administration

Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm. Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes. [8]

Ingredients

  • Human Papillomavirus type 16 L1 protein 20 micrograms
  • Human Papillomavirus type 18 L1 protein 20 micrograms
  • adjuvanted by AS04 containing:

3-O-desacyl-4’- monophosphoryl lipid A (MPL) 50 micrograms

L1 protein is in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni.

The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) and water for injections.[9]

Biotechnology

Cervarix is created using the L1 protein of the viral capsid. Recombinant activity in a baculovirus vector produces L1 protein spheres, which are very immunogenic. The viral proteins induce the formation of neutralizing antibodies. The vaccine contains no live virus and no DNA, so it cannot infect the patient. The vaccine was developed, in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, the University of Queensland in Australia, and the U.S. National Cancer Institute.[10]

Adjuvant

Adjuvant system 04 (AS04), contains aluminum hydroxide and monophosphoryl lipid A.[11]

Monophosphoryl lipid A, may also boost naturally-occurring antibodies to cholesterol anticholesterol.[12]

Clinical Trials

Phase II trials including 1100 women from North America and Brazil showed 100% protection against type 16 and type 18 HPV.[13] Phase III trials, including over 18,000 women from 14 countries in Pacific Asia, Europe, Latin America and North America. [14] The manufacturer is now conducting a trial to compare the immunogenecity and safety of Cervarix with Gardasil. [15]

Regulatory approval

  • Australia - Cervarix received approval in May 2007 in Australia for women ages 10 to 45.[16]
  • Philippines - On August 25, 2007 GlaxoSmithKline launched Cervarix in the Philippines after approval by the local Bureau of Food and Drugs.[17]
  • European Union - Cervarix was approved in September 2007 in the European Union.[18]
  • United States of America - The FDA approved Cervarix on 16 October 2009.[19][20]
    • On March 29, 2007 GlaxoSmithKline submitted a Biologic License Application (BLA) for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), to the U.S. Food and Drug Administration (FDA) which included data from clinical trials in almost 30,000 females 10 to 55 years of age and contains data from the largest Phase III cervical cancer vaccine efficacy trial to that date.[21]
    • GSK had awaited results of further trials to submit to the FDA. Approval had not been expected before late 2009.[22]

Warnings and Precautions

  • Syncope: Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Cervarix. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
  • Latex: The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper does not contain latex.
  • Preventing and Managing Allergic Vaccine Reactions: Prior to administration, the healthcare provider should review the immunization history for possible vaccine hypersensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision should be readily available in case of anaphylactic reactions following administration of Cervarix. [23]

Adverse Effects

  • The most common local adverse reactions and general adverse events in ≥20% of patients were pain, redness, and swelling at the injection site, fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
  • The most common general adverse events in ≥20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. [24]

Contraindications

  • Severe allergic reactions to any component of Cervarix. [25]

Use

Cervarix is used by the UK government for its national programme of vaccination for teenage and pre-teenage girls. This caused some controversy since Cervarix was chosen over Gardasil, even though Gardasil protects against other HPV types 6 and 11 (which cause genital warts).[26]

The study found that Cervarix generated more than 2x more antibodies than Gardasil for HPV type 16 and more than 6x more for HPV type 18 at seven months in all women aged 18–45 years (P<0.0001).

At seven months Cervarix also induced 2.7x more memory B cells than Gardasil for both HPV types 16 and 18 (P<0.0001) in women with no detectable B-cell response before vaccination.

Cervarix has been used to vaccinate girls aged 12–13 and 17–18 against HPV as part of the UK Government’s cervical cancer vaccination campaign.

The vaccine utilises the AS04 (Aka. "Adjuvant System 04") a trade name for combination of adjuvants used in various vaccine product by GlaxoSmithKline (GSK). It consists of aluminum hydroxide and monophosphoryl lipid A (MPL)

References

  1. ^ D'Souza, Gypsyamber; Kreimer, Aimee R.; Viscidi (2007-05-10). "Case–Control Study of Human Papillomavirus and Oropharyngeal Cancer". New England Journal of Medicine. 356 (19): 1944–1956. doi:10.1056/NEJMoa065497. PMID 17494927. {{cite journal}}: |first4= missing |last4= (help); |first5= missing |last5= (help); |first6= missing |last6= (help); |first7= missing |last7= (help); |first8= missing |last8= (help); More than one of |author2= and |last2= specified (help); More than one of |author3= and |last3= specified (help); Unknown parameter |first 3= ignored (|first3= suggested) (help)
  2. ^ "New data show Cervarix, GSK'S HPV 16/18 cervical cancer candidate vaccine, is highly immunogenic and well-tolerated in women over 25 years of age". GlaxoSmithKline. 2006-06-05. Retrieved 2007-01-27.
  3. ^ "Cervical Cancer Vaccines: Cervarix". Emory University. 2006-08-21. Retrieved 2007-01-27.
  4. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1097/GCO.0b013e328332c910, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1097/GCO.0b013e328332c910 instead.
  5. ^ "An Interview with Dr. Diane M. Harper, HPV Expert". 28 December 2010. Retrieved 12 January 2010. {{cite web}}: |first= missing |last= (help)
  6. ^ "Highlights of Prescribing Information" (PDF). Retrieved 2010-08-03.
  7. ^ "Highlights of Prescribing Information" (PDF). Retrieved 2010-08-03.
  8. ^ "Highlights of Prescribing Information" (PDF). Retrieved 2010-08-03.
  9. ^ http://emc.medicines.org.uk/medicine/20207/PIL/Cervarix/ Patient Information Leaflet
  10. ^ Who Invented the VLP Cervical Cancer Vaccines? McNeil, C., Journal of the National Cancer Institute, 2006, 98(7): 433.
  11. ^ "Strong & sustained immune response". Retrieved 2009-03-07.
  12. ^ see Nature.com - Clinical Pharmacology & Therapeutics, 2008, June, volume 83, page 813, Clinical development of TLR agonists as adjuvants: "post-alum adjuvant" candidates may reach beyond their intended purpose.
  13. ^ Kresge, Kristen Jill (2006). "Cervical cancer vaccines". International AIDS Vaccine Initiative. Retrieved 2006-08-28. {{cite web}}: Unknown parameter |month= ignored (help)
  14. ^ Paavonen J, Naud P, Salmerón J, et al. (2009). "Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women". Lancet 374:301-314. Retrieved 2010-07-29. {{cite web}}: Italic or bold markup not allowed in: |publisher= (help)CS1 maint: multiple names: authors list (link) CS1 maint: numeric names: authors list (link)
  15. ^ Einstein MH, Baron M, Levin MJ, et al. (2009). "Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in health women aged 18-45 years" (PDF). Human Vaccines 5:1–15. Retrieved 2010-07-29. {{cite web}}: Italic or bold markup not allowed in: |publisher= (help)CS1 maint: multiple names: authors list (link) CS1 maint: numeric names: authors list (link)
  16. ^ Glaxo cervical cancer shot approved in Australia Reuters (2007-05-21) Retrieved on 2007-05-25
  17. ^ GMA NEWS.TV, Second vaccine vs cervical cancer virus launched in Manila
  18. ^ "Glaxo prepares to launch Cervarix after EU okay". Reuters. 2007-09-24. Retrieved 2008-07-18.
  19. ^ "FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine". Retrieved 2009-10-30.
  20. ^ "October 16, 2009 Approval Letter - Cervarix". U.S. Food and Drug Administration (FDA). October 16, 2009. Retrieved 2009-11-13.
  21. ^ "Cervarix - Glaxo HPV Vaccine Filed With FDA". Vaccine Rx. March 29, 2007. Retrieved 2007-03-30.
  22. ^ "GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009". Retrieved 2008-07-18.
  23. ^ "Cervarix Prescribing Information" (PDF). Retrieved 2010-08-02.
  24. ^ "Cervarix Prescribing Information" (PDF). Retrieved 2010-08-02.
  25. ^ "Cervarix Prescribing Information" (PDF). Retrieved 2010-08-02.
  26. ^ Hawkes, Nigel (2008-07-18). "The Times - "Anger over Department of Health choice of cheaper cancer vaccine"". London. Retrieved 2008-07-18.

Further reading

External links

From the manufacturer of Cervarix, GSK

General

Retrieved from "https://en.wikipedia.org/w/index.php?title=Cervarix&oldid=378013478"